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British pharma industry responds to new Brexit guidance from MHRA
The ABPI has responded to new guidance, intended to prepare pharma companies for the end of the Brexit transition period, from the MHRA.
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Regulation & Legislation
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EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation
The EMA's PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
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UK to invest £500 million in next generation COVID-19 testing
Matt Hancock has announced that the £500 million investment will go towards new COVID-19 testing technologies and increased testing capacity.
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MHRA issues positive opinion to avelumab for Early Access to Medicines Scheme
The UK MHRA has given a positive scientific opinion for Merck and Pfizer's avelumab on the Early Access to Medicines Scheme (EAMS).
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WHO says 172 economies in talks for access to COVID-19 vaccines programme
The WHO has announced that many economies worldwide may participate in COVAX, an initiative aimed at providing countries with equitable access to COVID-19 vaccines.
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Canadian government strikes deals with Janssen and Novavax for COVID-19 vaccines
The Canadian government has agreed that Janssen will supply the country with 38 million doses of its COVID-19 vaccine, while Novavax has agreed to supply 76 million doses if its vaccine.
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FSD Pharma applies to FDA for trial testing FSD201 in COVID-19 patients
The Investigational New Drug Application (IND) is for a Phase II trial evaluating the safety and efficacy of FSD201 (ultramicronized PEA) in hospitalised COVID-19 patients.
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FDA expands emergency use authorisation for remdesivir to treat all COVID-19 patients
The FDA has expanded the Emergency Use Authorisation for Veklury (remdesivir) to treat all hospitalised patients with COVID-19.
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Beyond compliance: why embracing the FMD can transform medicine supply chain thinking
Relying on manual processes for managing serialised medicines at an individual pack level is a labour intensive and time-consuming process that can disrupt normal operations. In this article, Sébastien Sliski outlines how digitally enabled inventory processes, such as aggregation and consolidation, can help pharmaceutical wholesalers and hospital pharmacies meet their…
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Blenrep granted CMA for relapsed or refractory multiple myeloma
The European Commission granted the conditional marketing authorisation (CMA) based on data from a trial in which Blenrep achieved an overall response rate of 32 percent.
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Certificates of Compliance or Attestation of Conformity have no legal standing under UK Medical Device Regulations 2002
The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
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Exploring and deploying blockchain solutions in the life sciences and healthcare sectors
Blockchain is perhaps best known as the technology on which Bitcoin and other cryptocurrencies are built. Notwithstanding that adoption in the life sciences and healthcare sectors is still in its relative infancy, companies and other organisations in these sectors are increasingly exploring and deploying blockchain solutions. Here, legal experts James…
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Artificial pancreas for type 1 diabetes control given nod by FDA
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
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Continuous manufacturing: ICH Q13
Although steps have been taken to enable the implementation of continuous manufacturing in industry, a lack of global harmonisation in regulations has slowed the adoption of this promising emerging technology. Dave Elder discusses how ICH Q13 seeks to provide a harmonised approach to support this important initiative.
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The trials and tribulations of the medical devices and IVD regulations
This article explores the reasons behind the introduction of the EU Medical Device (MDR) and In Vitro Diagnostic Devices (IVDR) regulations, the problems that beset them and how COVID-19 finally persuaded the European Commission that a further year’s preparation time for full application of the regulations was necessary.
